WILMINGTON, Del.--(EON: Enhanced Online News)--AstraZeneca and MedImmune, its global biologics research and development
arm, will be underlining its scientific focus on cardiovascular, renal
and metabolic diseases (CVMD) with 28 presentations, including two
late-breaking trials, at the American Heart Association (AHA) Scientific
Sessions, November 11-15, 2017 in Anaheim, California.

“With the breadth of our scientific updates at AHA 2017, we are at
the forefront of the clinical debate, exploring the often unseen but
vital connections between cardiovascular, renal and metabolic diseases.
This approach embodies our commitment to improving outcomes for patients
while reducing long-term morbidity and mortality.”

Ludovic Helfgott, Vice President, Cardiovascular and Metabolic Diseases,
said: “With the breadth of our scientific updates at AHA 2017, we are at
the forefront of the clinical debate, exploring the often unseen but
vital connections between cardiovascular, renal and metabolic diseases.
This approach embodies our commitment to improving outcomes for patients
while reducing long-term morbidity and mortality.”

Key among the data being presented are two late-breaking presentations
selected by the AHA: the China-based DACAB study (Efficacy of Different
Antiplatelet Therapy Strategy after Coronary Artery Bypass Grafting);
and the EXSCEL (EXenatide Study of Cardiovascular Event Lowering) trial,
plus data for potential new CVMD medicines.

The DACAB study compares the use of ticagrelorplus aspirin
versus aspirin alone, and ticagrelor alone following elective coronary
artery bypass graft surgery (CABG), to assess patency of the grafts.
Ticagrelor is not approved in elective CABG and cannot be used as
monotherapy. (Session LBS.01).

A new analysis of the EXSCEL clinical trial, the largest and most
inclusive CV outcomes trial of any glucagon-like peptide-1 receptor
agonist (GLP-1 RA), with more than 14,500 patients at 687 trial sites
across 35 countries, aims to further demonstrate the effect of
exenatide once-weekly on CV morbidity and mortality in patients with
type-2 diabetes. This new analysis adds to results presented at the
recent annual meeting of the European Association for the Study of
Diabetes (EASD), and published simultaneously in the New
England Journal of Medicine. Exenatide is not indicated to reduce
the risk of CV outcomes. (Session LBS.04).

Presentations at AHA also include early stage data for potential new
medicines, as monotherapy and in combinations, in areas including
cardiac regeneration, chronic kidney disease, acute coronary
syndromes, and chronic heart failure. These include phase IIa data of
MEDI6012, a recombinant human lecithin-cholesterol acyltransferase
(LCAT) being evaluated for the treatment of coronary artery disease
(Session LB.APS.06 – S2107) and chronic heart failure (CHF), as well
as data from AZD5718 our 5-lipoxygenase activating protein (FLAP), a
potential treatment for ACS (Session IN.APS.02 – S4093).

IMPORTANT SAFETY INFORMATION FOR BRILINTA® (ticagrelor)
60-MG AND 90-MG TABLETS

Maintenance doses of aspirin above 100 mg reduce the effectiveness
of BRILINTA and should be avoided

CONTRAINDICATIONS

BRILINTA is contraindicated in patients with a history of intracranial
hemorrhage or active pathological bleeding such as peptic ulcer or
intracranial hemorrhage. BRILINTA is also contraindicated in patients
with hypersensitivity (eg, angioedema) to ticagrelor or any component
of the product

WARNINGS AND PRECAUTIONS

Dyspnea was reported in about 14% of patients treated with BRILINTA,
more frequently than in patients treated with control agents. Dyspnea
resulting from BRILINTA is often self-limiting

Discontinuation of BRILINTA will increase the risk of MI, stroke, and
death. When possible, interrupt therapy with BRILINTA for 5 days prior
to surgery that has a major risk of bleeding. If BRILINTA must be
temporarily discontinued, restart as soon as possible

Ticagrelor can cause ventricular pauses. Bradyarrhythmias including AV
block have been reported in the post-marketing setting. PLATO and
PEGASUS excluded patients at increased risk of bradyarrhythmias not
protected by a pacemaker, and they may be at increased risk of
developing bradyarrhythmias with ticagrelor

Avoid use of BRILINTA in patients with severe hepatic impairment.
Severe hepatic impairment is likely to increase serum concentration of
ticagrelor and there are no studies of BRILINTA in these patients

ADVERSE REACTIONS

The most common adverse reactions associated with the use of BRILINTA
included bleeding and dyspnea: In PLATO, for BRILINTA vs clopidogrel,
non-CABG PLATO-defined major bleeding (3.9% vs 3.3%) and dyspnea (14%
vs 8%); in PEGASUS, BRILINTA vs aspirin alone, TIMI Total Major
bleeding (1.7% vs 0.8%) and dyspnea (14% vs 6%)

DRUG INTERACTIONS

Avoid use with strong CYP3A inhibitors and strong CYP3A inducers.
BRILINTA is metabolized by CYP3A4/5. Strong inhibitors substantially
increase ticagrelor exposure and so increase the risk of adverse
events. Strong inducers substantially reduce ticagrelor exposure and
so decrease the efficacy of ticagrelor

Patients receiving more than 40 mg per day of simvastatin or
lovastatin may be at increased risk of statin-related adverse events

BRILINTA (ticagrelor) tablets is indicated to reduce the rate of
cardiovascular death, myocardial infarction (MI), and stroke in patients
with acute coronary syndrome (ACS) or a history of myocardial
infarction. For at least the first 12 months following ACS, it is
superior to clopidogrel.

BRILINTA also reduces the rate of stent thrombosis in patients who have
been stented for treatment of ACS.

DOSING

In the management of ACS, initiate BRILINTA treatment with a 180-mg
loading dose. Administer 90 mg twice daily during the first year after
an ACS event. After one year administer 60 mg twice daily. Use BRILINTA
with a daily maintenance dose of aspirin of 75-100 mg.

Exenatide extended-release causes an increased incidence in thyroid
C-cell tumors at clinically relevant exposures in rats compared to
controls. It is unknown whether BYDUREON causes thyroid C-cell tumors,
including medullary thyroid carcinoma (MTC), in humans, as the human
relevance of exenatide extended-release-induced rodent thyroid C-cell
tumors has not been determined

BYDUREON is contraindicated in patients with a personal or family
history of MTC or in patients with Multiple Endocrine Neoplasia
syndrome type 2 (MEN 2). Counsel patients regarding the potential risk
of MTC with the use of BYDUREON and inform them of symptoms of thyroid
tumors (eg, mass in the neck, dysphagia, dyspnea, persistent
hoarseness). Routine monitoring of serum calcitonin or using thyroid
ultrasound is of uncertain value for detection of MTC in patients
treated with BYDUREON

Acute Pancreatitis including fatal and non-fatal hemorrhagic or
necrotizing pancreatitis has been reported. After initiation, observe
patients carefully for symptoms of pancreatitis. If suspected,
discontinue promptly and do not restart if confirmed. Consider other
antidiabetic therapies in patients with a history of pancreatitis

Hypoglycemia Risk of hypoglycemia is increased when exenatide
is coadministered with insulin or insulin secretagogues. Consider
lowering the dose of these agents when coadministered with BYDUREON

Warfarin Increased international normalized ratio (INR)
sometimes associated with bleeding has been reported with concomitant
use of exenatide with warfarin. Monitor INR frequently until stable
upon initiation of BYDUREON

PREGNANCY

Use during pregnancy only if the potential benefit justifies the
potential risk to the fetus.

INDICATION AND LIMITATIONS OF USE

BYDUREON is indicated as an adjunct to diet and exercise to improve
glycemic control in adults with type 2 diabetes mellitus

Not recommended as first-line therapy for patients inadequately
controlled on diet and exercise

Not a substitute for insulin. Should not be used to treat type 1
diabetes mellitus or diabetic ketoacidosis

Not recommended for use with insulin

Do not coadminister with other exenatide-containing products

Not studied in patients with a history of pancreatitis. Consider other
antidiabetic therapies in patients with a history of pancreatitis

Cardiovascular, renal and metabolic diseases together form one of
AstraZeneca’s main therapy areas and platforms for future growth. By
following the science to understand more clearly the underlying links
between the heart, kidney and pancreas, AstraZeneca is investing in a
portfolio of medicines to protect organs and improve outcomes by slowing
disease progression, reducing risks and tackling co-morbidities. Our
ambition is to modify or halt the natural course of CVMDs and even
regenerate organs and restore function, by continuing to deliver
transformative science that improves treatment practices and CVMD health
for millions of patients worldwide.

About AstraZeneca

AstraZeneca is a global, science-led biopharmaceutical company that
focuses on the discovery, development and commercialization of
prescription medicines, primarily for the treatment of diseases in three
main therapy areas - Oncology, Cardiovascular & Metabolic Diseases and
Respiratory. The Company also is selectively active in the areas of
Autoimmunity, Neuroscience and Infection. AstraZeneca operates in over
100 countries and its innovative medicines are used by millions of
patients worldwide. For more information, please visit www.astrazeneca-us.com and
follow us on Twitter @AstraZenecaUS.

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